Table 1.
Sponsor | Product | Number of women enrolled | Status | Outcome of trial | Ref. |
---|---|---|---|---|---|
Agency for International Development, the Mellon Foundation/NIH | N-9 film | 1292 | Completed | No harm or benefit | [46] |
UNAIDS/Columbia Laboratories | N-9 gel (COL-1492 gel) | 1005 | Completed 2000 | Stopped with evidence of harm | [8] |
FHI/USAID | Savvy® | 4284 | Completed 2007 | Stopped due to futility, no evidence of harm | [47] |
FHI/USAID/CONRAD | Cellulose sulfate | 2160 | Completed 2007 | Stopped prematurely due to concerns from parallel trial interim results | [48] |
Population Council | Carraguard® | 6300 | Completed 2007 | No harm or benefit | [49] |
CONRAD/USAID/Bill and Melinda Gates Foundation | Cellulose sulfate | 1398 | Completed 2007 | Evidence of harm at interim analysis | [10] |
NIAD | Buffer gel 0.5% PRO 2000 | 3100 | Completed 2008 | 0.5% PRO 2000 showed 30% effectiveness: buffer gel did not have an effect | [11] |
MDP/MRC | PRO 2000 | 10,000 | Completed 2009 | 0.5% PRO 2000: no harm, no benefit | [12] |
LIFE Lab/FHI/USAID/ CONRAD/South African government | 1% Tenofovir | 889 | Completed 2009 | 39% effectiveness in HIV prevention | [30] |
NIAD | 1% Tenofovir | 5000 to be enrolled | Ongoing, enrollment started in September 2009 | Aim for completion June 2012 | [Unpublished data] |
FHI: Family Health International; MDP: Microbicides Development Program; MRC: Medical Research Council UK; N-9: Nanoxynol-9; NIAD: National Institute of Allergies and Infectious Diseases; UNAIDS: Joint United Nations Programme on HIV/AIDS; USAID: United States Agency for International Aid.